The semi-annual report only raises the treatment and avoids the revenue, and the "unspeakable secrets" of Car-T therapy

China Times (chinatimes.net.cn) reporter Sun Mengyuan Yu Na Beijing report

"Since the launch of CAR-T products, it has indeed demonstrated the efficacy beyond the expected effect. In addition to covering as much as possible, the company will continue to improve CAR-T production technology. It is hoped that the cost can be reduced as much as possible, so that this drug will be allowed to make this drug. Serving more patients. "Wu Yifang, chairman of Fosun Pharmaceutical, said at the 2022 mid -term performance media communication conference held on August 30.

CAR-T therapy is a chimeric antigen receptor T cell immunotherapy. It is a new type of precision targeting therapy for tumors. As of now, a total of 8 CAR-T therapy has been approved globally. Among them, there are two CAR-T products listed in China, namely Fosun Kate's Akelon Saitor injection (product name: Yi Kaida) and Yaoming Junuo's Ruki Olun Saitor injection (product name:: Binota).

In June and September 2021, Fosun Kate's Yicaida and Yaoming Junuo's Beinida was approved for listing. Today, with the financial reports of major companies, CAR-T products have also handed over the first anniversary of the listing. According to the statistics of the "Huaxia Times" reporter, the two CAR-T therapy approved in China so far has completed a total of more than 500 patients' return. From the existing clinical data, both therapies have shown good security and good security and and. Effective.

Yaoming Juo, which was listed in Hong Kong stocks, announced CAR-T related revenue data. According to the 2021 annual report, Yaoming Junuo's core CAR-T product Beinada revenue was 30.8 million, and the gross profit margin was 29.4%. In the half-annual report of 2022, Yaoming Juuo said that the gross profit margin in the first half of the year has increased. To 35%. The CAR-T-related revenue data released by Fosun Pharmaceuticals is relatively limited, and it has not even mentioned it in the semi-annual report this year.

Avoid revenue data

Why didn't you disclose Yica's financial data? "Huaxia Times" reporter called Fosun Kate's relevant person in charge. You can refer to their reports. "

At the 2022 mid-term performance media communication conference held by Fosun Pharmaceutical on August 30, Wu Yifang did not talk about Yicaida's revenue and profits. It is still with some real world data we carried out in the world, including some real world data now, and the real world data overseas is relatively consistent. The entire effect is really good. "

In the previous semi -annual report, Fosun Pharmaceutical did not disclose Yi Kaida's financial data.

In June 2021, Yikai of Fosun Kate reached the first CAR-T cell treatment product in China to be approved to be listed. Adult patients. Official data show that Fosun Kate's Yica has benefited over 200 Chinese patients.

From the perspective of the efficacy, as of now, Ruijin Hospital Affiliated to Shanghai Jiaotong University Medical College has treated more than 30 patients through commercial CAR-T products. There are 19 patients who can be evaluated during the treatment phase. %, The complete relief rate (CR) is as high as 63.1%.

Unlike Yikaida, the financial data of Yao Ming Juuo "Beinada" and the market.

In the semi -annual report of 2022, Yaoming Juuo said that the gross profit margin of Beinida in the first half of the year had increased to 35%, with an income of about 6.607 million yuan, and the gross profit was about 23.131 million yuan. (RELMA-CEL), which was successfully commercialized after being approved by the National Pharmaceutical Supervision and Administration of Drug Administration on September 1, 2021.

In September 2021, Yin Ming Junuo's Beinida was approved to go public for the treatment of recurrence or refractory (R/R) large B -cell lymphoma (LBCL) of adult patients after the second or above systematic treatment. Yaoming Junuo WeChat public account disclosed that as of August 15, 2022, Benota had successfully completed the return treatment of 260 Chinese patients (including clinical research and commercialization).

According to Yaoming Juuo's financial report, as of December 31, 2021, Binota's sales were RMB 30.797 million and gross profit was RMB 9 million. In the first half of 2022, a total of 77 Binota prescriptions were issued to complete the return of 64 patients for patients with R/R LBCL. With the implementation of the cost reduction plan, Beinada's gross profit margin increased from 29%to 35.0%from 35.0%. Essence The company expects that with the process of commercialization and more patients undergoing Binota, Binota's sales revenue will continue to increase.

Available problems

Since the first CAR-T product came out in 2017, this innovative therapy has been highly hoped for its curative advantage. Guojin Securities analyzed the sales of CAR-T products listed in 2017-2021, and the conclusion that its compound annual growth rate was 165%from 2017-2021. Yescarta, as the world's first CAR-T product, has only $ 6 million in 2017, while sales in 2021 have reached $ 587 million.

Guojin Securities Research Report pointed out that shortly after the realization of China's cell therapy field, as far as the two products currently listed, the competitive environment is relatively mild, and there is still much room for clinical needs. The development of the market is similar to the global market, entering the stage of rapid volume. According to the forecast of Fhstanalin, the market size of China's CAR-T cell therapy in 2022 is expected to reach 1.5 billion yuan, and it is expected to increase to 5.3 billion yuan by 2024. By 2030, it is expected to achieve a market size of 23.9 billion yuan. However, because CAR-T cell therapy is an individualized treatment method that uses the human body's immune system. It is a disposable return treatment. Each patient is an independent batch. To reduce costs, the patient's payment pressure is relatively large. For many patients and families, the cost of treatment is "sky -high".

According to a reporter from the Huaxia Times, Kymriah, which is used to treat leukemia, is priced to treat $ 475,000 a time; Geilide is used to treat YESCARTA for the treatment of B -cell lymphoma. The retail price of Lun Sai is also 1.2 million yuan/bag (about 68ml).

Guojin Securities Research reports that at present, CAR-T products have been listed in China, which mainly stems from materials such as personalized preparation, more expensive imported carriers and other materials, as well as too little product preparation.

Deng Zhidong, general manager of Hainan Boao Medical Technology Co., Ltd., said in an interview with the reporter of Huaxia Times that the research and development cycle is long, the cost is large, and the production procedure is complicated. After the listing of the pharmaceutical company, the pharmaceutical company needs to return funds in the short term, recover costs, and achieve profitability. In addition, it is in the market window period, the market is highly concentrated and lacking competition. All these are the current CAR-T drugs are high.

"We have also been working hard to continue to improve in CAR-T's production technology. We are also continuously optimizing production and technology. I hope to reduce costs as much as possible and let this drug serve more patients." Wu Yifang said that Wu Yifang said. Essence

Guojin Securities believes that with the localization of various raw materials, the increase in preparation efficiency and the increase in the number of preparations, the cost and price of cell therapy products will decrease significantly. In addition, the intervention of various insurance products will also improve its availability.

Wu Yifang told the reporter of "Huaxia Times" that for CAR-T, the most extensive payment ability is, so innovative payment does lay a good foundation for this drug to benefit more patients. In the future, new patients may be covered with more insurance, but the specific number to how much the proportion cannot be calculated.

Thanks to the follow-up of commercial insurance and the benefits of people in major cities, the burden of medical expenses of CAR-T cell therapy is decreasing. Taking Yikaida as an example, it has been incorporated into 44 provinces and cities, Huimin Insurance and more than 50 commercial insurance, and nearly a hundred treatment centers filing.

"Different cities (in the proportion) will be different. Some of the existing cities with innovative payment can be reimbursed at least 30%. In this way Sex, so that more people can see hope and have the opportunity to get their second life. "Wu Yifang said.

More entry

It is precisely the huge market prospects that CAR-T has become one of the hottest areas of the biomedical industry in recent years. Domestic CAR-T is facing excessive full-quality homogeneous competition. According to incomplete statistics, as of the end of 2021, more than 20 domestic companies in China have been in the listing stage of the listing, and more than half are CD19 targeted therapies for malignant blood tumors.

In February of this year, CAR-T products independently developed by the legendary creature CILTA-CEL were approved by the FDA for the treatment of 4 or more treatment (including protease inhibitors, including protease inhibitors, including proteases, The recurrence or refractory multiple bone marrowoma (R/R MM) patients with immunomotive regulators and anti-CD38 monoclonal antibodies) are also the first Chinese original CAR-T cell therapy products listed in the United States.

Data disclosed by the legendary biological parent company Kings Rui showed that the net sales of the first complete listing quarter of Sidaki Olun was $ 24 million, with a pricing of 465,000 US dollars (about RMB 2.93 million). He served about 51 patients.

In order to break through the internal rolls, many companies are seeking differentiated competition.

According to Fosun Pharmaceutical, Yicaida's second adaptation (for the treatment of recurrence or refractory inert, non -Hodgkin lymphoma (R/R INHL), including filter lymphoma and edge region lymphoma Adult patients) In 2021, they have been approved in China to conduct clinical trials and have been included in breakthrough treatment drug procedures; as of the end of the reporting period, the indications have entered the clinical trial stage in China. Yi Kaida's third adaptation (for the treatment of an adult B -cell lymphoma, an adult B -cell lymphoma that is invalid or recurred within 12 months after the first line of immunotherapy, R/R LBCL) was approved in China in August 2022 in China Carry out clinical trials.

In addition to expanding more indications, Fosun Kate's second CAR-T cell therapy products are used to treat FKC889 for treatment of adultPatients were approved in China in March 2022 to conduct clinical trials in China.In the field of solid tumors, Fosun Kate actively deploy R & D pipelines and strengthens independent research and development capabilities. It is accelerating the promotion of five preclinical projects for physical tumors, and is committed to making up the huge gaps in the application of physical tumors.

"Improve the accessibility of CAR-T drugs, and can start from multiple aspects. First, the large-scale and standardized production of pharmaceutical companies, improve production efficiency, and reduce costs and increase efficiency.Market supply and competition; Third, the implementation of government guidance, incorporate policy price negotiations, and carry out research on scientific research on alternatives. "Deng Zhidong said.

Council reporter: Editor of Yan Yuan: Chen Yanpeng

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